Trial Outcomes & Findings for Study of the CAT RX Aspiration Catheter When Used in Patients With Large Occlusive Thrombus in Coronary Arteries (NCT NCT03957473)
NCT ID: NCT03957473
Last Updated: 2023-10-10
Results Overview
Cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or new or worsening New York Heart Association Class IV heart failure
Recruitment status
COMPLETED
Target enrollment
400 participants
Primary outcome timeframe
30 days
Results posted on
2023-10-10
Participant Flow
Participant milestones
| Measure |
Single Arm
Single Arm - Use of Indigo Aspiration System with CAT RX Aspiration Catheter (mechanical thrombectomy) in high thrombus burden acute coronary vessel occlusions
Indigo Aspiration System: Indigo Aspiration System with CAT RX Aspiration Catheter and optional Indigo Separator 4
|
|---|---|
|
Overall Study
STARTED
|
400
|
|
Overall Study
COMPLETED
|
370
|
|
Overall Study
NOT COMPLETED
|
30
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of the CAT RX Aspiration Catheter When Used in Patients With Large Occlusive Thrombus in Coronary Arteries
Baseline characteristics by cohort
| Measure |
Single Arm
n=400 Participants
Single Arm - Use of Indigo Aspiration System with CAT RX Aspiration Catheter (mechanical thrombectomy) in high thrombus burden acute coronary vessel occlusions
Indigo Aspiration System: Indigo Aspiration System with CAT RX Aspiration Catheter and optional Indigo Separator 4
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
255 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
145 Participants
n=99 Participants
|
|
Age, Continuous
|
60.4 years
STANDARD_DEVIATION 12.21 • n=99 Participants
|
|
Sex: Female, Male
Female
|
95 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
305 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
14 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
378 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
12 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
3 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
31 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
341 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
400 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 30 daysCardiovascular death, recurrent myocardial infarction, cardiogenic shock, or new or worsening New York Heart Association Class IV heart failure
Outcome measures
| Measure |
Single Arm
n=400 Participants
Single Arm - Use of Indigo Aspiration System with CAT RX Aspiration Catheter (mechanical thrombectomy) in high thrombus burden acute coronary vessel occlusions
Indigo Aspiration System: Indigo Aspiration System with CAT RX Aspiration Catheter and optional Indigo Separator 4
|
|---|---|
|
Composite of:
|
14 Participants
|
SECONDARY outcome
Timeframe: ProcedureTIMI flow grading range 0-3, with higher grading representing better outcome
Outcome measures
| Measure |
Single Arm
n=400 Participants
Single Arm - Use of Indigo Aspiration System with CAT RX Aspiration Catheter (mechanical thrombectomy) in high thrombus burden acute coronary vessel occlusions
Indigo Aspiration System: Indigo Aspiration System with CAT RX Aspiration Catheter and optional Indigo Separator 4
|
|---|---|
|
Final TIMI Flow Grade
TIMI 0
|
0 Participants
|
|
Final TIMI Flow Grade
TIMI 1
|
0 Participants
|
|
Final TIMI Flow Grade
TIMI 2
|
10 Participants
|
|
Final TIMI Flow Grade
TIMI 3
|
390 Participants
|
SECONDARY outcome
Timeframe: ProcedureTIMI Thrombus grading range 0-5, with lower grading representing better outcome
Outcome measures
| Measure |
Single Arm
n=400 Participants
Single Arm - Use of Indigo Aspiration System with CAT RX Aspiration Catheter (mechanical thrombectomy) in high thrombus burden acute coronary vessel occlusions
Indigo Aspiration System: Indigo Aspiration System with CAT RX Aspiration Catheter and optional Indigo Separator 4
|
|---|---|
|
Final TIMI Thrombus Grade
Grade 0
|
398 Participants
|
|
Final TIMI Thrombus Grade
Grade 1
|
1 Participants
|
|
Final TIMI Thrombus Grade
Grade 2
|
1 Participants
|
|
Final TIMI Thrombus Grade
Grade 3
|
0 Participants
|
|
Final TIMI Thrombus Grade
Grade 4
|
0 Participants
|
|
Final TIMI Thrombus Grade
Grade 5
|
0 Participants
|
SECONDARY outcome
Timeframe: ProcedureMyocardial blush grading range 0-3, with higher grading representing better outcome
Outcome measures
| Measure |
Single Arm
n=400 Participants
Single Arm - Use of Indigo Aspiration System with CAT RX Aspiration Catheter (mechanical thrombectomy) in high thrombus burden acute coronary vessel occlusions
Indigo Aspiration System: Indigo Aspiration System with CAT RX Aspiration Catheter and optional Indigo Separator 4
|
|---|---|
|
Myocardial Blush Grade
Grade 0
|
0 Participants
|
|
Myocardial Blush Grade
Grade 1
|
0 Participants
|
|
Myocardial Blush Grade
Grade 2
|
1 Participants
|
|
Myocardial Blush Grade
Grade 3
|
399 Participants
|
SECONDARY outcome
Timeframe: ProcedureOutcome measures
| Measure |
Single Arm
n=400 Participants
Single Arm - Use of Indigo Aspiration System with CAT RX Aspiration Catheter (mechanical thrombectomy) in high thrombus burden acute coronary vessel occlusions
Indigo Aspiration System: Indigo Aspiration System with CAT RX Aspiration Catheter and optional Indigo Separator 4
|
|---|---|
|
Distal Embolization Rate
|
3 Participants
|
SECONDARY outcome
Timeframe: 180 DaysOutcome measures
| Measure |
Single Arm
n=400 Participants
Single Arm - Use of Indigo Aspiration System with CAT RX Aspiration Catheter (mechanical thrombectomy) in high thrombus burden acute coronary vessel occlusions
Indigo Aspiration System: Indigo Aspiration System with CAT RX Aspiration Catheter and optional Indigo Separator 4
|
|---|---|
|
Stent Thrombosis
|
9 Participants
|
SECONDARY outcome
Timeframe: 30 DaysOutcome measures
| Measure |
Single Arm
n=400 Participants
Single Arm - Use of Indigo Aspiration System with CAT RX Aspiration Catheter (mechanical thrombectomy) in high thrombus burden acute coronary vessel occlusions
Indigo Aspiration System: Indigo Aspiration System with CAT RX Aspiration Catheter and optional Indigo Separator 4
|
|---|---|
|
Stroke
|
3 Participants
|
SECONDARY outcome
Timeframe: 30 DaysOutcome measures
| Measure |
Single Arm
n=400 Participants
Single Arm - Use of Indigo Aspiration System with CAT RX Aspiration Catheter (mechanical thrombectomy) in high thrombus burden acute coronary vessel occlusions
Indigo Aspiration System: Indigo Aspiration System with CAT RX Aspiration Catheter and optional Indigo Separator 4
|
|---|---|
|
Major Bleeding
|
4 Participants
|
SECONDARY outcome
Timeframe: 180 DaysOutcome measures
| Measure |
Single Arm
n=400 Participants
Single Arm - Use of Indigo Aspiration System with CAT RX Aspiration Catheter (mechanical thrombectomy) in high thrombus burden acute coronary vessel occlusions
Indigo Aspiration System: Indigo Aspiration System with CAT RX Aspiration Catheter and optional Indigo Separator 4
|
|---|---|
|
All-Cause Mortality
|
9 Participants
|
SECONDARY outcome
Timeframe: 180 DaysOutcome measures
| Measure |
Single Arm
n=400 Participants
Single Arm - Use of Indigo Aspiration System with CAT RX Aspiration Catheter (mechanical thrombectomy) in high thrombus burden acute coronary vessel occlusions
Indigo Aspiration System: Indigo Aspiration System with CAT RX Aspiration Catheter and optional Indigo Separator 4
|
|---|---|
|
Cardiovascular Death
|
4 Participants
|
SECONDARY outcome
Timeframe: 180 DaysOutcome measures
| Measure |
Single Arm
n=400 Participants
Single Arm - Use of Indigo Aspiration System with CAT RX Aspiration Catheter (mechanical thrombectomy) in high thrombus burden acute coronary vessel occlusions
Indigo Aspiration System: Indigo Aspiration System with CAT RX Aspiration Catheter and optional Indigo Separator 4
|
|---|---|
|
Recurrent MI
|
10 Participants
|
SECONDARY outcome
Timeframe: 180 DaysOutcome measures
| Measure |
Single Arm
n=400 Participants
Single Arm - Use of Indigo Aspiration System with CAT RX Aspiration Catheter (mechanical thrombectomy) in high thrombus burden acute coronary vessel occlusions
Indigo Aspiration System: Indigo Aspiration System with CAT RX Aspiration Catheter and optional Indigo Separator 4
|
|---|---|
|
Cardiogenic Shock
|
8 Participants
|
SECONDARY outcome
Timeframe: 180 DaysOutcome measures
| Measure |
Single Arm
n=400 Participants
Single Arm - Use of Indigo Aspiration System with CAT RX Aspiration Catheter (mechanical thrombectomy) in high thrombus burden acute coronary vessel occlusions
Indigo Aspiration System: Indigo Aspiration System with CAT RX Aspiration Catheter and optional Indigo Separator 4
|
|---|---|
|
Class IV Heart Failure
|
4 Participants
|
SECONDARY outcome
Timeframe: 180 DaysOutcome measures
| Measure |
Single Arm
n=400 Participants
Single Arm - Use of Indigo Aspiration System with CAT RX Aspiration Catheter (mechanical thrombectomy) in high thrombus burden acute coronary vessel occlusions
Indigo Aspiration System: Indigo Aspiration System with CAT RX Aspiration Catheter and optional Indigo Separator 4
|
|---|---|
|
Incident of Device Related SAEs
|
0 Participants
|
Adverse Events
Single Arm
Serious events: 144 serious events
Other events: 30 other events
Deaths: 10 deaths
Serious adverse events
| Measure |
Single Arm
n=400 participants at risk
Single Arm - Use of Indigo Aspiration System with CAT RX Aspiration Catheter (mechanical thrombectomy) in high thrombus burden acute coronary vessel occlusions
Indigo Aspiration System: Indigo Aspiration System with CAT RX Aspiration Catheter and optional Indigo Separator 4
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.50%
2/400 • Procedure through 180 days
|
|
Cardiac disorders
Acute myocardial infarction
|
2.0%
8/400 • Procedure through 180 days
|
|
Cardiac disorders
Angina pectoris
|
1.2%
5/400 • Procedure through 180 days
|
|
Cardiac disorders
Angina unstable
|
1.2%
5/400 • Procedure through 180 days
|
|
Cardiac disorders
Arteriospasm coronary
|
0.25%
1/400 • Procedure through 180 days
|
|
Cardiac disorders
Atrial fibrillation
|
1.5%
6/400 • Procedure through 180 days
|
|
Cardiac disorders
Bradycardia
|
1.0%
4/400 • Procedure through 180 days
|
|
Cardiac disorders
Cardiac arrest
|
1.8%
7/400 • Procedure through 180 days
|
|
Cardiac disorders
Cardiac failure chronic
|
1.0%
4/400 • Procedure through 180 days
|
|
Cardiac disorders
Cardiogenic shock
|
0.75%
3/400 • Procedure through 180 days
|
|
Cardiac disorders
Coronary artery disease
|
0.25%
1/400 • Procedure through 180 days
|
|
Cardiac disorders
Dressler's syndrome
|
0.25%
1/400 • Procedure through 180 days
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.25%
1/400 • Procedure through 180 days
|
|
Cardiac disorders
Ventricular fibrillation
|
0.50%
2/400 • Procedure through 180 days
|
|
Cardiac disorders
Ventricular tachycardia
|
0.75%
3/400 • Procedure through 180 days
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.25%
1/400 • Procedure through 180 days
|
|
Gastrointestinal disorders
Retroperitoneal haematoma
|
0.25%
1/400 • Procedure through 180 days
|
|
Gastrointestinal disorders
Vomiting
|
0.25%
1/400 • Procedure through 180 days
|
|
General disorders
Asthenia
|
0.25%
1/400 • Procedure through 180 days
|
|
General disorders
Chest pain
|
1.2%
5/400 • Procedure through 180 days
|
|
General disorders
Non-cardiac chest pain
|
0.25%
1/400 • Procedure through 180 days
|
|
General disorders
Vascular stent occlusion
|
0.25%
1/400 • Procedure through 180 days
|
|
General disorders
Vascular stent thrombosis
|
1.0%
4/400 • Procedure through 180 days
|
|
Infections and infestations
COVID-19
|
0.50%
2/400 • Procedure through 180 days
|
|
Infections and infestations
COVID-19 pneumonia
|
0.25%
1/400 • Procedure through 180 days
|
|
Infections and infestations
Osteomyelitis acute
|
0.25%
1/400 • Procedure through 180 days
|
|
Infections and infestations
Pneumonia
|
1.5%
6/400 • Procedure through 180 days
|
|
Infections and infestations
Pneumonia influenzal
|
0.25%
1/400 • Procedure through 180 days
|
|
Infections and infestations
Sepsis
|
0.50%
2/400 • Procedure through 180 days
|
|
Infections and infestations
Septic shock
|
0.25%
1/400 • Procedure through 180 days
|
|
Infections and infestations
Urinary tract infection
|
0.50%
2/400 • Procedure through 180 days
|
|
Injury, poisoning and procedural complications
Arterial bypass stenosis
|
0.25%
1/400 • Procedure through 180 days
|
|
Injury, poisoning and procedural complications
Procedural hypotension
|
0.75%
3/400 • Procedure through 180 days
|
|
Injury, poisoning and procedural complications
Procedural pneumothorax
|
0.25%
1/400 • Procedure through 180 days
|
|
Injury, poisoning and procedural complications
Vascular access site haemorrhage
|
0.50%
2/400 • Procedure through 180 days
|
|
Investigations
Blood creatinine increased
|
0.25%
1/400 • Procedure through 180 days
|
|
Investigations
Transaminases increased
|
0.25%
1/400 • Procedure through 180 days
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.25%
1/400 • Procedure through 180 days
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.25%
1/400 • Procedure through 180 days
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.25%
1/400 • Procedure through 180 days
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.25%
1/400 • Procedure through 180 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
0.25%
1/400 • Procedure through 180 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.25%
1/400 • Procedure through 180 days
|
|
Nervous system disorders
Encephalopathy
|
0.25%
1/400 • Procedure through 180 days
|
|
Nervous system disorders
Ischaemic stroke
|
1.8%
7/400 • Procedure through 180 days
|
|
Nervous system disorders
Prescynope
|
0.25%
1/400 • Procedure through 180 days
|
|
Nervous system disorders
Syncope
|
0.25%
1/400 • Procedure through 180 days
|
|
Nervous system disorders
Transient ischaemic attack
|
0.25%
1/400 • Procedure through 180 days
|
|
Renal and urinary disorders
Acute kidney injury
|
1.5%
6/400 • Procedure through 180 days
|
|
Renal and urinary disorders
Calculus urinary
|
0.25%
1/400 • Procedure through 180 days
|
|
Renal and urinary disorders
Renal failure
|
0.50%
2/400 • Procedure through 180 days
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary eodema
|
0.25%
1/400 • Procedure through 180 days
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
1.2%
5/400 • Procedure through 180 days
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.25%
1/400 • Procedure through 180 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.25%
1/400 • Procedure through 180 days
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.25%
1/400 • Procedure through 180 days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.25%
1/400 • Procedure through 180 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.25%
1/400 • Procedure through 180 days
|
|
Surgical and medical procedures
Coronary revascularisation
|
0.25%
1/400 • Procedure through 180 days
|
|
Vascular disorders
Accelerated hypertension
|
0.50%
2/400 • Procedure through 180 days
|
|
Vascular disorders
Deep vein thrombosis
|
0.25%
1/400 • Procedure through 180 days
|
|
Vascular disorders
Haemorrhage
|
1.0%
4/400 • Procedure through 180 days
|
|
Vascular disorders
Hypertension
|
0.25%
1/400 • Procedure through 180 days
|
|
Vascular disorders
Hypotension
|
0.75%
3/400 • Procedure through 180 days
|
|
Vascular disorders
Orthostatic hypotension
|
0.25%
1/400 • Procedure through 180 days
|
|
Cardiac disorders
Coronary artery dissection
|
0.25%
1/400 • Procedure through 180 days
|
Other adverse events
| Measure |
Single Arm
n=400 participants at risk
Single Arm - Use of Indigo Aspiration System with CAT RX Aspiration Catheter (mechanical thrombectomy) in high thrombus burden acute coronary vessel occlusions
Indigo Aspiration System: Indigo Aspiration System with CAT RX Aspiration Catheter and optional Indigo Separator 4
|
|---|---|
|
Cardiac disorders
Angina pectoris
|
0.50%
2/400 • Procedure through 180 days
|
|
Cardiac disorders
Arteriospasm coronary
|
0.50%
2/400 • Procedure through 180 days
|
|
Cardiac disorders
Atrial fibrillation
|
0.50%
2/400 • Procedure through 180 days
|
|
Cardiac disorders
Cardiac failure chronic
|
0.25%
1/400 • Procedure through 180 days
|
|
Cardiac disorders
Coronary artery disease
|
0.25%
1/400 • Procedure through 180 days
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.50%
2/400 • Procedure through 180 days
|
|
General disorders
Chest pain
|
1.0%
4/400 • Procedure through 180 days
|
|
Infections and infestations
Post procedural cellulitis
|
0.25%
1/400 • Procedure through 180 days
|
|
Injury, poisoning and procedural complications
Incision site haemorrhage
|
0.25%
1/400 • Procedure through 180 days
|
|
Injury, poisoning and procedural complications
Vascular access site haemorrhage
|
0.50%
2/400 • Procedure through 180 days
|
|
Nervous system disorders
Dizziness
|
0.25%
1/400 • Procedure through 180 days
|
|
Nervous system disorders
Encephalopathy
|
0.25%
1/400 • Procedure through 180 days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.25%
1/400 • Procedure through 180 days
|
|
Vascular disorders
Deep vein thrombosis
|
0.25%
1/400 • Procedure through 180 days
|
|
Vascular disorders
Haematoma
|
0.25%
1/400 • Procedure through 180 days
|
|
Vascular disorders
Haemodynamic instability
|
0.50%
2/400 • Procedure through 180 days
|
|
Vascular disorders
Haemorrhage
|
0.25%
1/400 • Procedure through 180 days
|
|
Vascular disorders
Hypotension
|
0.25%
1/400 • Procedure through 180 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place